Trial · NCT01453049
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 33
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 | Baseline (Week 0) and Week 24 | Blood samples of participants were collected for HbA1c assessment. HbA1c is a form of hemoglobin that is measured primarily to identify the average plasma glucose concentration over a 2- to 3-month period. The American Diabetes Association has recommended an HbA1c value below 53 millimoles per mole (mmol/mol) (7.0%) for most participants. Change from Baseline in HbA1c was calculated as the value at Week 24 minus the value at Baseline. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24 | Baseline (Week 0) and Week 24 | Blood samples of participants were collected for FPG assessment. The FPG test, also known as the fasting blood sugar test, measures blood sugar levels after the participant has not eaten (fasted) for 12 to 14 hours. Change from Baseline in FBG was calculated as the value at Week 24 minus the value at Baseline. |
| Secondary | Number of HbA1c Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | Blood samples of participants were collected for HbA1c assessment. HbA1c responders were defined as participants who had achieved HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (LOCF). |
| Secondary | Number of FPG Responders and Non-responders | Baseline (Week 0) and Week 24 (LOCF) | Blood samples of participants were collected for FPG assessment. FPG responders are definded as participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG level \< 6.1 mmol/L at Week 24 (LOCF). |
| Secondary | Number of Participants Who Achieved HbA1c <7%, HbA1c <=6.5%, or Who Achieved a Decrease of >=0.7% From Baseline | Baseline (Week 0) and Week 24 (LOCF) | Blood samples of participants were collected for HbA1c assessment. |
| Secondary | Change From Baseline in Fasting Proinsulin and Insulin at Week 24/Early Withdrawal (EW) | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12-14 hours were collected for fasting proinsulin (precursor of insulin) and insulin assessment. Preproinsulin is sequentially processed via proinsulin, through intermediate proteolytic cleavage products, to insulin and C-peptide before release from the beta cell granule by exocytosis. Elevated levels of proinsulin are considered indicative of beta cell dysfunction. Insulin is a hormone that regulates carbohydrate and fat metabolism in the body. Change from Baseline was calculated as the value at Week 24/ EW minus the value at Baseline (Week 0). |
| Secondary | Change From Baseline in Homeostasis Model Assessment Sensitivity (HOMA-S) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12-14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-S is calculated using the following model to predict glucose and insulin concentrations=(FI\[milliunits (mU)/milliliter (ml)\]\*FG \[millimoles per liter (mmol/l)\])/22.5. numerator, num.; denominator, denom. |
| Secondary | Change From Baseline in Homeostasis Model Assessment Beta-cell Function (HOMA-B) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12 to 14 hours were collected for fasting glucose (FG) and insulin (FI) assessment. The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance (a condition in which natural hormone insulin becomes less effective in lowering blood sugars) and beta-cell (specialized cells in the pancreas producing insulin) function. HOMA-B is calculated using the following mathematical model to predict glucose and insulin concentrations=(20\*FI\[mU/ml\])/(FG\[mmol/l\]-3.5). |
| Secondary | Number of Participants at Various Dose Levels at Week 24/EW | Week 24/EW | The number of participants at the different dose levels at Week 24/EW was recorded. The different dose levels for Rosi + Glim are: Dose level 1, Rosi 4 mg + Glim 1 mg; Dose level 2, Rosi 4 mg + Glim 2 mg; Dose level 3, Rosi 4 mg + Glim 4 mg. The different dose levels for Glim are: Dose level 1, Glim 1 mg; Dose level 2, Glim 2 mg; Dose level 3, Glim 4 mg. |
| Secondary | Change From Baseline in Total Cholesterol (TC), High Density Lipoprotein-cholesterol (HDL-C), Low Density Lipoprotein-cholesterol (LDL-C), and Triglyceride (TG) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C, LDL-C, TG) assessment. The lipid profile asesses the risk of heart disease. Change from Baseline in TC, HDL-C, LDL-C, and TG was calculated as the value at Week 24)/EW minus the value at Baseline. |
| Secondary | Change From Baseline in Blood Urea Nitrogen (BUN), Sodium, Potassium, Chloride, Calcium, and Phosphorus at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants were collected for BUN and electrolyte (sodium, potassium, chloride, calcium, and phosphorus) assessment. The electrolyte balance asseses the condition of the heart and the kidneys, and BUN assesses the condition of the kidneys. Change from Baseline in BUN, sodium, potassium, chloride, calcium, and phosphorus was calculated as the value at Week 24/EW minus the value at Baseline. |
| Secondary | Change From Baseline in the Ratio of TC/HDL-C and LDL-C/HDL-C at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants who had fasted for 12 to 14 hours were collected for lipid profile (TC, HDL-C and LDL-C) assessment. The ratio of TC/HDL-C and LDL-C/HDL-C was calculated. Change from Baseline in the ratio of TC/HDL-C and LDL-C/HDL-C was calculated as the value at Week 24/EW minus the value at Baseline. For TC/HDL-C, the numerator is TC, and the denominator is HDL-C. For LDL-C/HDL-C, the numerator is LDL-C, and the denominator is HDL-C. |
| Secondary | Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Change from Baseline in hs-CRP was calculated as the value at Week 24/EW minus the value at Baseline. |
| Secondary | Percent Change From Baseline in High Sensitivity C-reactive Protein (Hs-CRP) at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants were collected for hs-CRP assessment. CRP is a marker of inflammation. High levels of CRP predict the risk of heart disease and diabetes. Percent change from Baseline in hs-CRP was calculated as the value at Visit 8 (Wk 24)/ EW minus the value at Baseline divided by value at Wk 24/ EW multiplied by 100. |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 24/EW | Baseline (Week 0) and Week 24/EW | EQ-5D is used as a measure of health outcome and includes single-item measures (coded on a 3-point scale \[1, no problems; 2, some problems; 3, severe problems\]) of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The instrument includes a global rating of current health using a visual analog scale (VAS): 0 (worst imaginable) to 100 (best imaginable). Health states may be converted to a single summary index by applying a formula that attaches values to each of the levels in each dimension. The index scale is -0.111 to 1. A lower index indicates worse health. |
| Secondary | Change From Baseline in Adjusted Diabetes Quality of Life (A-DQOL) Scores at Week 24/EW | Baseline (Week 0) and Week 24/EW | In diabetic participants, QOL, anxiety, and depression were measured by the A-DQOL scale . There are 46 core items (10 additional items for adolescents) and 4 major dimensions: treatment satisfaction, treatment impact, worry about long-term complications, and worry about social/vocational issues. Participants respond to all items on a 5-point Likert scale: 1, no impact, no worries, or always satisfied; 5, always affected, always worried, or never satisfied. The total score is a sum of the individual scores of all 46 items (range of 46 to 230); a lower score indicates a better QOL. |
| Secondary | Number of Participants With Hypoglycemic Events | Week 24/EW | Blood samples of participants were collected for the assessment of blood glucose levels. Hypoglycemia is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants; participants with HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG \<6.1 mmol/L at Week 24 (FPG responders) were evaluated. |
| Secondary | Number of Hypoglycemic Events | Week 24/EW | A hypoglycemic event is a condition that occurs when the blood glucose is below 70 mg/dL or 4 mmol/L. All participants, participants with HbA1c \<7%, or who achieved a decrease of \>= 0.7% from Baseline at Week 24 (HbA1c responders); and participants who had a \>=1.7 mmol/L decrease from Baseline FPG or who achieved a FPG \<6.1 mmol/L at Week 24 (FPG responders) were evaluated. |
| Secondary | Number of Participants With a Bone Fracture | Week 24/EW | Participants with a break in the continuity (fracture) of the bone were evaluated. |
| Secondary | Change From Baseline in White Blood Cell (WBC) Count and Platelet Count at Week 24/EW | Baseline (Week 0) and Week 24/EW | Blood samples of participants were collected for WBC count and platelet count assessment. Change from Baseline in WBC count and platelet count was calculated as the value at Week 24/EW minus the value at Baseline. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT01453049/registered